Compliance4All, Online
2017-01-19
Overview: Review of basic polymer chemistry and changes in polymer
characteristics can be anticipated and designed for. Learn how to plan for
post radiation resistance and lifetime functionality. All radiation modalities
(gamma, e-beam, x-ray) will be reviewed for a basic understanding of
the sterilization process and the influences that product design and
assembly can have on success.
The following subjects will be covered in detail:
Materials Guidances - AAMI TIR # 17, ASTM Sterilization validation and Bioburden Shelf Life Test Methods - Accelerated Aging design Product design The influences of product assembly (molding, automation, etc.)’ Material selection and post irradiation degradation Regulatory Guidances - AAMI/ISO 11137, TIR #17 Packaging Design and Materials
Why should you Attend: "Do it right the first time", choose the most functional and radiation
resistant materials for your medical device instead of going through the
post launch cycle of product revisions. Also learn the basis for choosing
the optimum sterilization modality based on materials, product design,
bioburden, and logistics. Learn how to "think like a molecule" and plan
and design around radiation induced changes in materials qualities
(color, odor, brittleness). How to avoid the materials that are "APT" to
fail.
Areas Covered in the Session: Polymers Chemistry - choosing the best polymer candidate Gamma, E-beam, X-ray sterilization Accelerated Aging Product Validation Sterilization Validation - Establishing the baseline dose
Who Will Benefit: Medical product design engineers Sterilization Experts Quality Management and Engineers Regulatory Affairs
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